Silo Pharma Achieves New Milestone for SP-26 Therapeutic -Initiates IND Enabling Study of Topical Ketamine Formulation
Silo Pharma, Inc. (Nasdaq: SILO) has initiated the initial dosing of its IND-enabling study for SP-26, a new time-released, topical ketamine formulation aimed at treating fibromyalgia. Conducted by Experimur, the study evaluates the tolerability of SP-26 to determine the maximum tolerated dose. With a market for fibromyalgia treatments projected to grow from $764 million in 2020 to $1.4 billion by 2027, this development could position Silo favorably. The company is also preparing a pre-IND submission to the FDA to pursue the 505(b)(2) regulatory pathway.
- Initiation of dosing in the IND-enabling study for SP-26.
- Potential market growth for fibromyalgia treatments from $764 million in 2020 to $1.4 billion by 2027.
- None.
ENGLEWOOD CLIFFS, NJ, Nov. 11, 2022 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced initial dosing in its IND-enabling study of SP-26, its novel time-released, topical formulation of ketamine.
The objective of this safety evaluation study, conducted by Experimur, a Frontage Company, is to evaluate the tolerability of the SP-26 compound to establish a maximum tolerated dose. The new drug is intended to treat fibromyalgia, a chronic condition causing widespread musculoskeletal pain accompanied by memory issues, sleep problems and fatigue.
Eric Weisblum, Chief Executive Officer of Silo Pharma, stated, “Our team is excited about this milestone in our collaboration with our joint venture partner Zylö Therapeutics, headquartered in South Carolina. Together we have developed a delivery method for a new ketamine formulation that has shown in pre-clinical studies to hold and distribute the drug in a time-released fashion and reduce neuropathic nerve pain. This IND-enabling study coupled with our existing data brings us another step closer to testing in human patients.”
Silo Pharma recently began working with a regulatory partner to prepare a pre-Investigational new drug (IND) package submission to the U.S. Food and Drug Administration (FDA). The Company intends to pursue the 505(b)(2) regulatory pathway for SP-26.
Silo cites that according to Fortune Business Insights, the market for fibromyalgia treatments was valued at US
About Silo Pharma
Silo Pharma. Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the healthcare industry. For more information, visit www.silopharma.com.
Forward-Looking Statements
All statements other than statements of historical fact in this announcement are forward-looking statements that involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy, and financial needs. Investors can identify these forward-looking statements by words or phrases such as "may," "will," "expect," "anticipate," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company's filings with the SEC.
Contact
800-705-0120
investors@silopharma.com
1 Fortune Business Insights; Fibromyalgia Treatment Market Size, Share and Trends. September 2022.
FAQ
What is SP-26 and its purpose?
What is the significance of the IND-enabling study for SP-26?
What market potential does Silo Pharma see for fibromyalgia treatments?
Who is conducting the SP-26 study?
What regulatory pathway is Silo Pharma pursuing for SP-26?
